eligibility_summary
Eligibility: Adults 18–75 with consent, histologically confirmed high‑risk NMIBC (HG/G3: CIS, T1, >3 cm, or multiple/recurrent), no resectable Ta/T1 disease after TURBT (residual CIS allowed), unsuitable for or refusing radical surgery, HER2 IHC 1+/2+/3+, ECOG 0–1, adequate organ function. Exclude: T2+ or metastatic disease, urothelial cancer outside bladder, anticancer therapy <4 wks, major surgery planned/recent, allergy to DV/excipients.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06378242 tests Disitamab Vedotin (RC48) delivered by intravesical instillation for high-risk HER2-expressing non–muscle-invasive bladder cancer. Intervention: Disitamab Vedotin is an antibody–drug conjugate (ADC): a humanized anti‑HER2 monoclonal antibody linked via a cleavable linker to the cytotoxic payload monomethyl auristatin E (MMAE), a microtubule inhibitor. Mechanism of action: the antibody binds HER2 (ERBB2) on urothelial tumor cells, is internalized, and releases MMAE to disrupt microtubules, causing cell-cycle arrest and apoptosis, Fc-mediated effector functions (e.g., ADCC) and a local bystander effect may also contribute. Target cells/pathways: HER2-overexpressing urothelial carcinoma cells, HER2 signaling axis, microtubule dynamics. Intravesical delivery concentrates the ADC in the bladder to maximize local antitumor activity with limited systemic exposure.